Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
placement of fissure sealant
fluoride varnish
silver fluoride
placebo control
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring tooth decay, fluoride, sealant, prevention
Eligibility Criteria
Inclusion Criteria:
- school children in good general health
- have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries
Exclusion Criteria:
- children with major systemic disease or taking long-term medications
- not cooperative or refuse dental treatments
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
fissure sealant
fluoride varnish
SDF solution
control
Arm Description
single placement of resin fissure sealant on tooth surface
application of a 5% sodium fluoride varnish every 6 months
application of a 38% silver diamine fluoride solution onto tooth surface every year
application of water onto tooth surface every year
Outcomes
Primary Outcome Measures
dental caries
tooth decay appearing as a cavity on tooth surface
Secondary Outcome Measures
Full Information
NCT ID
NCT01446107
First Posted
September 23, 2011
Last Updated
April 28, 2021
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01446107
Brief Title
Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
Official Title
A Randomized Controlled Trial on the Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of the lesions are in the fissures of the first permanent molars. This study aims to investigate the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride solution. The cost-effectiveness of these methods will also be compared. About 400 children, aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted in school using portable dental lights and instruments to identify teeth that need caries prevention. The children will be randomly allocated to one of the three test or the control groups. Treatments will be provided in the study primary schools according to standard clinical protocols. Follow-up examinations will be carried out every six months for 30 months to assess whether the preventive methods are successful, i.e. no dental caries develops in the treated teeth. The findings of this study will be of great value to dentists and public health authorities in deciding on the most appropriate dental caries prevention programme for school children in China and other developing countries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
tooth decay, fluoride, sealant, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
502 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fissure sealant
Arm Type
Experimental
Arm Description
single placement of resin fissure sealant on tooth surface
Arm Title
fluoride varnish
Arm Type
Experimental
Arm Description
application of a 5% sodium fluoride varnish every 6 months
Arm Title
SDF solution
Arm Type
Experimental
Arm Description
application of a 38% silver diamine fluoride solution onto tooth surface every year
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
application of water onto tooth surface every year
Intervention Type
Other
Intervention Name(s)
placement of fissure sealant
Intervention Description
placement of resin-based fissure sealant at baseline without replacement
Intervention Type
Other
Intervention Name(s)
fluoride varnish
Intervention Description
topical applications of a 5% sodium fluoride (NaF) varnish onto tooth surface every 6 months
Intervention Type
Other
Intervention Name(s)
silver fluoride
Intervention Description
topical applications of a 38% silver diamine fluoride (SDF) solution onto tooth surface every year
Intervention Type
Other
Intervention Name(s)
placebo control
Intervention Description
application of water onto tooth surface every year
Primary Outcome Measure Information:
Title
dental caries
Description
tooth decay appearing as a cavity on tooth surface
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
school children in good general health
have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries
Exclusion Criteria:
children with major systemic disease or taking long-term medications
not cooperative or refuse dental treatments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward CM Lo, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22736448
Citation
Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012 Aug;91(8):753-8. doi: 10.1177/0022034512452278. Epub 2012 Jun 26.
Results Reference
derived
Learn more about this trial
Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
We'll reach out to this number within 24 hrs